Early ambulation versus immobilization in the management of patients with distal deep venous thrombosis

Early ambulation versus immobilization in the management of patients with distal deep venous thrombosis

Ayman Omar,MD; Hisham Abu Greda,MD Vascular Surgical Unit, Department of General Surgery,

Menoufiya University Hospitals, Shebin El-Kom, Egypt.

Abstract

Background: The encouragement of early ambulation with compression rather than bed-rest becomes a matter of controversy.

Aim: To evaluate the benefits of compression and walking exercises in comparison with bed rest in the acute stage of distal deep venous thrombosis.

Methods: Twenty-eight patients with distal DVT that were randomized into 2 groups. The

first group: 14 patients received low-molecular-weight heparin (LMWH) associated  with bed rest & leg elevation for 7-10 days. The second group: 14 patients received LMWH and were allowed to be ambulant  after 1-2 days with elastic compression  stocks. Patients • assessment was essentially concerning with the reduction of leg pain & swelling and also checking out the propagation                           of    thrombosis  and/or  development  of    pulmonary  embolism.

Results: Leg pain was reduced or abolished in 12/14 patients in the ambulant group compared to 10/14 patients in the bed-rest group. Also; the reduction  of limb swelling in the ambulant group was better than that of the bed-rest one.Furthermore; propagation of thrombus was more in the bed-rest group (2/14) compared to the ambulant one (1/14).

Conclusion:  Patients with acute distal DVT treated with LMWH should be encouraged  to

walk with medical compression stockings.

Keywords: Deep vein thrombosis, ambulation, pulmonary embolism.

Introduction:

Acute DVT still has a bad reputation both in the eye of the patients and in the mind of medical professionals  because of serious leg problems, pulmonary embolism  and death. Confinement to  bed  and complete immobilization appeared as logical treatment option and was never challenged. Nowadays, with rapid anticoagulant treatment the risk of symptomatic recurrence of thrombosis and pulmonary embolism has been  virtually decreased, but the optimal  treatment of the signs and symptoms is still ignored. Also; there are an increasing number of patients with DVT that treated entirely on the out-patient basis.1,2,3

Several prospective  studies did not show any increased danger of pulmonary embolism if mobile patients are treated with LMWH and keep  walking with  compression bandages regardless of the size or location of the thrombi.4, 5 Furthermore; many authors had postulated that patients with  DVT  recover

much faster when they are encouraged to walk with finn compression bandage.1,6,7,8 However; until now, evidence-based data proving  the advantages of active walking exercises with compression  is lacking.

Aim of the work:

The aim of the present study is to evaluate the value of early ambulation and compression versus  the  current standard of  bed rest  in association  with heparinization with LMWH in patients with distal deep vein thrombosis in a sample of Egyptian patients.

Patients and methods:

This prospective study was carried out at Menoufyia University Hospitals. Patients with popliteal or calf acute  DVT and fitting  the inclusion criteria of the study were included. Patients, recruitment started from January 2009 till January 2010. The diagnosis ofDVT was essentially  based on   duplex  scanning.

Inclusion criteria:

Patients   18 years with their first episode of acute distal  DVT  (popiteal  and/or  calf).

Exclusion criteria:

Patients with  symptomatic pulmonary embolism as chest pain and dyspnea, patients with concomitant  arterial diseases, recurrent DVT, proximal DVT, cancer patients, patients with  recent surgery, orthopedic patients, pregnant females, sever hypertension (systolic

> 200 mm Hg or diastolic > 100 mm Hg), atrial

fibrillation or  known  right  to  left  shunt.

Patients  were randomized into 2 groups. The  first  group: Patients received low­ molecular-weight heparin (LMWH) associated with bed rest & leg elevation  for 7-10 days. The second group: Patients received LMWH and were allowed to be ambulant after 1-2 days.

Low-molecular-weight heparin given to all patients in both groups was Enoxaparin  in a dose of lmg/kg/SC/12hrs. Also; all patients have  warned below  knee  class II  elastic compression stocks at the proposed time. Patients' assessment:

All patients in both groups were evaluated

in respect to:

- Improvement of associated clinical features

(pain, swelling, .. ect).

-  Propagation  of   thrombosis  and/or

-  Development of  pulmonary embolism.

Patients showed suspicious  of pulmonary embolization (chest pain or dyspnea) during the first 10 days of their treatment underwent necessary screening tests  for pulmonary embolism.These included; arterial blood gases, ECG changes of right heart strain classically S1Q3T3 & spiral CT chest whenever necessary.

Table (1): Patient's demography.

Randomization:

Protocol-eligible patients were prospectively randomized according to a computer-generated code, based on the order of their admission to the  study. Each  patient was  assigned to ambulant or bed-ridden group. When the patient agreed to take part in the study, he or she opened a sealed opaque envelop holding the number  that  correlates with his/her  tum of admittance  to the study. Therefore,  once the envelope has been opened,  the investigator knows  the treatment strategy  that would be applied.

Statistical analysis:

The usefulness  of ambulation  in reducing the limb circumference and in alleviating the patients' symptoms was analyzed by the t-test for  two  samples with  unequal variance (confidence level  95.0%). where data were normally  distributed and expressed by their mean  ± standard error  of mean  (SEM). Differences were considered significant if the P value was 0.05 or lower. In this study; the analysis of data  was  carried  out  using  the Minitab 13.1 Statistical Package (Mini tab Inc, Pennsylvania, USA).

Results:

Patient demography:

Twenty-eight patients participated in the study (14 patients in each group). The age difference in both groups was not statistically significant (53.6 ± 15.22 versus 56.92 ± 14.87; P = 0.4). Also; the males participated in both groups were more than females, however; the difference  was not significant  (55% vs 40%; P = 0.3). Patients' demography is shown in Table(l).

Clinical features associated with DVT at patients' first presentation:

Pain was the common presenting feature among all patients in both groups. However; leg swelling was a common feature also, presented in 64.3% & 85.7% in the bed-rest

and ambulant groups respectively. Also; local limb warmth was an associated common feature, presented in 64.3% & 78.6% in the bed-rest and ambulant groups respectively. This is shown in Table(2).

Table (2): Clinical features associated with DVT at patients' first presentlltion.

Clinical features associated with DVT

after one week:

Improvement of clinical features in both groups was a common finding. Limb swelling subsided in 6/9 (66.6 %) in the bed-rest group

versus 11112 (91.6 %) in the ambulant group. This difference in improvement among both groups was statistically significant (95% CI=23.3-92.7, Chi Square= 5.353; P = 0.02). This is shown in Table(3).

Table (3): Clinical features associated with DVT after one week.

Differences in limb girth at patients' first presentation:

There   were   little   differences  in  the

circumferences (ankle/ mid-leg/ mid-thigh) between the affected limb & the sound limb in   both    groups.  The   differences  in

circumferences in the bed-rest group were (1.47 ± 1.03, 2.67 ± 1.50 & 1.13 ± 1.22) versus (1.93 ± 1.53, 2.93 ± 1.45 & 1.06 ± 1.47) in the ambulant group. However; such differences between both groups was not significant. This is shown in Table(4).

Table (4): Differences in limb girth atpatients' first presentation.

Differences in limb girth after one week: After one week of treatment, both groups

of patients showed  reduction in their  limb swelling  compared to the sound  limb.  The differences in the limb circumferences in the bed-rest group were {1.2± 1.28, 1.40 ± 1.53

and 1.07 ± 1.31 em) and in the ambulant group

{1.30 ± 0.80, 1.90 ± 1.28 and 1.09 ± 1.30 em). However; such  differences between both groups were not significant. This is shown in Table(5).

Table (5): Differences in limb girth after one week.

Duplex findings at patients' first

presentation:

Vein thrombosis at  patients'  first presentation was located to the calf veins in 5 patients in the bed-rest group versus 8 patients in the ambulant group. Also; involvement of the popliteal vein was detected in 3 patients in the bed-rest group  versus  2 patients in the

ambulant  group. Furthermore; the combined calf and popliteal veins thrombosis was detected in 6 patients  in the bed-rest  group versus  4 patients in the ambulant group. The difference inallocation of venous thrombosis among both groups of patients was not significant. This is shown in Table(6).

Table (6): Duplex findings at patients' first presentation.

Duplex findings after one week:

Propagation of thrombosis appeared in the bed-rest group in 2 patients 2/14 (14%), and appeared in one patient in the ambulant group

1/14 (7%). No clinical suspicioun of pulmonary embolism appeared in both groups of patients.

Discussion:

In the past few decades, patients with active DVT were placed on bed rest for periods up to 7-10 days due to the fear of PE among patients who remain active.9,10,11 Bed rest is recommended  because of the concern of clot dislodgment by ambulation & to decrease the limb pain & edema.12

Conversely;  bed rest can be incriminated in promoting blood stasis and propagation of thrombosis with subsequent elongation of the hospital stay.13,14,15 Furthermore; more recent practice has included earlier ambulation, but there has been reluctance to begin ambulation immediately after diagnosis and  initial management ofDVT.In practice, there appears to be no standard protocol for activity progression in the early days of treating DVT.16

World-wide; early  ambulation is rarely recommended as part of the initial management of thrombo-embolic disorders. However; as soon as a level of effective anticoagulation has been reached, ambulation is allowed in many centers in the world.17 This approach is being opposed by other authors who believed that a

new or progression of DVT  was  observed among patients managed with early ambulation.5,9

Home therapy  for DVT is a running  new era over the last couple of decades especially with the introduction ofLMWH. The rationale of home therapy of acute DVT is essentially based many factors:

- The new nature anticoagulation

- the encouragement of early ambulation &

-cutting the cost of hospital stay.

There  is eligibility for home  therapy. Anticoagulation is the main line of treatment ofDVT, as well as PE, consisting usually of LMWH, promptly followed by oral therapy.18

The  study design in regards to the hypothesis, aim,  methods & results were incorporated in order to investigate the usefulness & safety of early ambulation in patients with acute DVT compared to patients confined  to bed rest for a proposed  period. Although this particular area of research has been explored world-wide in limited centers, we did try to find out the natural history of this dilemma ina sample ofEgyptian patients{Mid­ Delta territory).

This has been  achieved  by recruiting 28 patients (28 lower  limbs)  with  acute  deep venous thrombosis of calf veins and popliteal vein of the leg. The patients were randomized into two equal groups.The first group:patients were confined to bed rest & leg elevation for

7-10 days. The second group: patients were allowed to be ambulant after 1-2 days. All patients  in both groups received  therapeutic heparinization with LMWH overlapped by oral anticoagulant and have warned  below knee

class nelastic stocks.

Patients demography:

The two groups were comparable in regards to the age of patients  (53.6 ± 15.22  versus

56.92 ± 14.87 years respectively) and also in

regards to their gender type (5 females in bed­ rest group & 4 females in ambulant  group). Females  were infrequent than males in both groups. This difference  was not statistically significant  (55% versus 40%; P = 0.3). The impact of age & patients' gender does not seem

to have any impact on the progress or outcome of either  treatment options.  These  came in agreement  with  that  in  literature.19

Limb  pain  & swelling  in  both  groups: Pain  and   swelling  of   the   leg   with symptomatic DVT have considerable subjective relevance for the patient's quality oflife. Until now  these   parameters have  been  widely neglected in most  studies  concentrating on therapeutic outcomes. BUi.ttler and Partsch 20 have reported the usefulness of walking with compression on relieving  pain & edema in

patients with acute DVT.

In the present  study; leg pain associated with acute DVT was reduced or abolished in

12/14 patients in the ambulant group compared to 10/14  patients in the  bed-rest group. However; this difference was not statistically significant (P<0.5).Furthermore; the reduction of leg swelling was achieved in all patients in both groups as mentioned earlier.The reduction of limb swelling  in the ambulant  group was better than that of the bed-rest one. However although  the reduction  in limb swelling  was not significant  (P < 0.1), it was reflected  on patients' comfort  & was  appreciated. Our results came in agreement with that of previous studies of  Partsch H in 20057 & Nadia et ai.8 in2009.

Propagation of thrombosis in both groups:

In 2004; BHittler  and  Partsch4 did  a randomized controlled trial on 53 patients with proximal DVT; comparing bed rest for 9 days without compression with walking exercises using compression stockings or bandages. All patients were treated with therapeutic doses of LMWH. Thrombus size  was  assessed by duplex examination on day 0 and 9. An increase in the length of the thrombus in the femoral vein was seen in 40% of individuals in the bed-rest group, and in 28% of those who were encouraged to walk with compression bandages or stockings.The difference was not statistically significant However; the thrombus size showed a statistically significantly greater enlargement in those patients confined to bed compared to ambulatory patients with compression therapy (P = 0.01).

Also; the American Venous Forum,21 has

reported that the progression of thrombi in the femoral vein was greater and occurred  more frequently in patients encountered to bed rest during  their  anticoagulation therapy.8,22,23

Inthe present study and after one week of

either treatment regimen; pulmonary embolism was not suspected clinically in any  patients. However;  serial  duplex scanning did reveal that the propagation of thrombus was more in the bed-rest group (2/14) compared to the ambulant one (1/14) respectively; P = 0.2). The difference was not significant. Truthfully;  we did not measure the propagation of thrombosis by centimeters, but we did investigate the involvement of  more  proximal vein segment. That is why we did not encounter with  significant findings  in  thrombus propagation than that achieved in previous studies.

Our findings confirm those from previous reports suggesting that bed rest has no influence on the risk of developing pulmonary embolism among patients with acute DVT of the lower limbs. Furthermore; early ambulation has other beneficial effects by alleviating pain, improving the quality of life, and lowering the rate of post­ thrombotic syndrome. Since it may allow home treatment or early discharge from the hospital, it  might   be  cost-effective.

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